Aurobindo Pharma secures USFDA approval for Glycerol Phenylbutyrate Oral Liquid

Aurobindo Pharma announced that it has received final approval from the US Food & Drug Administration to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.

The product is bioequivalent and therapeutically equivalent to the reference listed drug Ravicti Oral Liquid 1.1 grams per mL of Horizon Therapeutics U.S. Holding LLC.

The company stated that the product will be manufactured at its Unit-III facility and will be launched immediately.

According to IQVIA MAT data, the approved product has an estimated market size of US$ 50.2 million for the twelve months ending February 2026.

With this approval, Aurobindo Pharma now has a total of 579 ANDA approvals from the USFDA, including 556 final approvals and 23 tentative approvals.

Glycerol Phenylbutyrate Oral Liquid is indicated as a nitrogen-binding agent for the management of patients with urea cycle disorders who cannot be managed by dietary protein restriction and or amino acid supplementation alone.

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